Data

SNB101 from AIMS bio science

  1. Individual concentration plots
  2. Mean+sd concentration plots
  3. Naive NCA results
    1. After administration (time >= 0)
    2. From the beginning of administration (time >= -2)
  4. Dose-normalized NCA results
    1. After administration (time >= 0)
    2. From the beginning of administration (time >= -2)
  5. Simple covariate analysis using correlation & linear regression

Plots are shown in interactive way Click the name (irinotecan, SN-38, SN-38G) on the label for the seperated view (Right side of the plot)

Individual concentration plots

Mean+sd concentration plot

Naive NCA results

NCA result with individual dose

After end of adminitration (time >= 0)

End of administration시점부터의 NCA 계산함 (time < 0는 분석에서 제외함)

Irinotecan

Subject CMAX TMAX LAMZHL AUCLST AUCIFO
C1_01-001 70.61 0.0 5.725037 161.188 198.5126
C2_03-001 73.34 0.0 4.948905 381.790 396.9263
C3_02-002 229.40 0.5 24.534894 2548.050 2812.4609
C4_03-002 272.41 0.0 18.604625 1296.453 1353.3550
C4_02-003 721.77 0.5 11.479251 1570.610 1605.7194
C4_01-002 491.28 0.0 13.187731 2172.370 2212.7049
C4_01-003 271.76 0.0 9.436067 1385.737 1414.5978
C4_01-004 664.98 0.5 11.394901 2787.418 2822.2690
C5_02-004 459.54 0.0 11.239705 2171.032 2239.7861
C5_03-003 549.59 0.0 10.536213 2466.932 2531.3828
C5_01-006 485.88 0.0 9.955497 4205.870 4266.7680
C5_02-005 665.90 0.0 11.937573 7453.140 7526.1625
C5_02-006 669.55 0.0 9.880453 3215.610 3276.0490
C5_01-007 662.53 0.0 9.722780 5630.738 5690.2120
C5_03-004 436.79 0.0 10.274070 2385.870 2448.7168
C6_03-005 496.74 0.0 10.430611 2738.073 2801.8768
C6_02-007 959.88 0.0 11.021335 3649.655 3717.0728

SN-38

Subject CMAX TMAX LAMZHL AUCLST AUCIFO
C1_01-001 144.502 0.0 4.392132 148.4135 157.2719
C2_03-001 96.280 0.0 2.409351 159.5100 163.5421
C3_02-002 124.610 0.5 17.823767 576.1425 594.3996
C4_03-002 322.940 0.5 95.303849 473.3325 654.8251
C4_02-003 579.240 0.0 6.284927 580.2775 594.6037
C4_01-002 747.660 0.0 13.018502 1141.2275 1154.5625
C4_01-003 526.530 0.0 19.188157 931.6800 951.3347
C4_01-004 1107.660 0.0 14.801469 1285.4300 1315.7527
C5_02-004 527.520 0.0 48.247269 956.3175 1054.4621
C5_03-003 722.620 0.0 5.465684 1134.9100 1146.0283
C5_01-006 682.590 0.0 24.641777 1958.4125 2008.5388
C5_02-005 909.970 0.0 78.245129 3370.0450 3529.2112
C5_02-006 863.380 0.0 13.163867 1070.5950 1097.3729
C5_01-007 820.140 0.0 10.526648 1314.6175 1336.0308
C5_03-004 396.940 0.0 8.313664 672.7125 689.6242
C6_03-005 419.370 0.0 3.694194 520.1200 527.6347
C6_02-007 1050.120 0.0 18.685614 1175.7600 1213.7703

SN-38G

Subject CMAX TMAX LAMZHL AUCLST AUCIFO
C1_01-001 165.072 0.0 19.023959 637.1770 660.9176
C2_03-001 178.300 0.0 33.155656 649.5500 729.4319
C3_02-002 185.780 0.5 14.666856 963.3975 986.8849
C4_03-002 260.950 0.0 33.320084 1284.5450 1429.2379
C4_02-003 304.010 0.0 13.222703 1025.5200 1057.3775
C4_01-002 299.760 0.5 13.761658 1299.9775 1326.3832
C4_01-003 1296.700 0.0 54.601868 3898.9275 4002.1212
C4_01-004 1668.840 0.0 11.722381 3954.4775 3977.6467
C5_02-004 242.130 0.0 16.440958 1481.6650 1519.3787
C5_03-003 392.000 0.0 19.202091 1550.2125 1580.9626
C5_01-006 728.060 0.0 21.469494 5889.8375 5911.8290
C5_02-005 586.940 0.0 31.815546 4986.6950 5019.2841
C5_02-006 436.440 0.0 15.552769 1647.6325 1663.5634
C5_01-007 1214.940 0.0 9.344536 5354.1800 5383.5693
C5_03-004 1311.600 0.5 10.027999 3791.8175 3802.0893
C6_03-005 731.660 0.0 77.867546 1869.4250 1949.1858
C6_02-007 444.990 0.0 13.289757 1956.7900 1970.4029

Summary

Parameter irinotecan, N = 171 SN-38, N = 171 SN-38G, N = 171
CMAX 481.291 ± 239.339 590.710 ± 312.784 614.598 ± 474.079
LAMZHL 11.430 ± 4.444 22.600 ± 26.625 24.029 ± 18.090
AUCLST 2,718.855 ± 1,805.316 1,027.618 ± 757.709 2,484.813 ± 1,754.701
AUCIFO 2,783.210 ± 1,815.559 1,069.939 ± 783.684 2,527.663 ± 1,748.679
1 Mean ± SD

From the beginning of administration (time >= -2)

용량 주입 시점 (time = -2) 부터의 NCA를 계산함 (Continuous infusion, duration은 2hr 로 설정)

Irinotecan

Subject CMAX TMAX LAMZHL AUCLST AUCIFO
C1_01-001 70.61 0.0 5.725037 161.188 198.5126
C2_03-001 73.34 0.0 4.948905 381.790 396.9263
C3_02-002 229.40 0.5 24.534894 2548.050 2812.4609
C4_03-002 272.41 0.0 18.604625 1296.453 1353.3550
C4_02-003 721.77 0.5 11.479251 1570.610 1605.7194
C4_01-002 491.28 0.0 13.187731 2172.370 2212.7049
C4_01-003 271.76 0.0 9.436067 1385.737 1414.5978
C4_01-004 664.98 0.5 11.394901 2787.418 2822.2690
C5_02-004 459.54 0.0 11.239705 2171.032 2239.7861
C5_03-003 549.59 0.0 10.536213 2466.932 2531.3828
C5_01-006 485.88 0.0 9.955497 4205.870 4266.7680
C5_02-005 665.90 0.0 11.937573 7453.140 7526.1625
C5_02-006 669.55 0.0 9.880453 3215.610 3276.0490
C5_01-007 662.53 0.0 9.722780 5630.738 5690.2120
C5_03-004 436.79 0.0 10.274070 2385.870 2448.7168
C6_03-005 496.74 0.0 10.430611 2738.073 2801.8768
C6_02-007 959.88 0.0 11.021335 3649.655 3717.0728

SN-38

Subject CMAX TMAX LAMZHL AUCLST AUCIFO
C1_01-001 144.502 0.0 4.392132 148.4135 157.2719
C2_03-001 96.280 0.0 2.409351 159.5100 163.5421
C3_02-002 124.610 0.5 17.823767 576.1425 594.3996
C4_03-002 322.940 0.5 95.303849 473.3325 654.8251
C4_02-003 579.240 0.0 6.284927 580.2775 594.6037
C4_01-002 747.660 0.0 13.018502 1141.2275 1154.5625
C4_01-003 526.530 0.0 19.188157 931.6800 951.3347
C4_01-004 1107.660 0.0 14.801469 1285.4300 1315.7527
C5_02-004 527.520 0.0 48.247269 956.3175 1054.4621
C5_03-003 722.620 0.0 5.465684 1134.9100 1146.0283
C5_01-006 682.590 0.0 24.641777 1958.4125 2008.5388
C5_02-005 909.970 0.0 78.245129 3370.0450 3529.2112
C5_02-006 863.380 0.0 13.163867 1070.5950 1097.3729
C5_01-007 820.140 0.0 10.526648 1314.6175 1336.0308
C5_03-004 396.940 0.0 8.313664 672.7125 689.6242
C6_03-005 419.370 0.0 3.694194 520.1200 527.6347
C6_02-007 1050.120 0.0 18.685614 1175.7600 1213.7703

SN-38G

Subject CMAX TMAX LAMZHL AUCLST AUCIFO
C1_01-001 165.072 0.0 19.023959 637.1770 660.9176
C2_03-001 178.300 0.0 33.155656 649.5500 729.4319
C3_02-002 185.780 0.5 14.666856 963.3975 986.8849
C4_03-002 260.950 0.0 33.320084 1284.5450 1429.2379
C4_02-003 304.010 0.0 13.222703 1025.5200 1057.3775
C4_01-002 299.760 0.5 13.761658 1299.9775 1326.3832
C4_01-003 1296.700 0.0 54.601868 3898.9275 4002.1212
C4_01-004 1668.840 0.0 11.722381 3954.4775 3977.6467
C5_02-004 242.130 0.0 16.440958 1481.6650 1519.3787
C5_03-003 392.000 0.0 19.202091 1550.2125 1580.9626
C5_01-006 728.060 0.0 21.469494 5889.8375 5911.8290
C5_02-005 586.940 0.0 31.815546 4986.6950 5019.2841
C5_02-006 436.440 0.0 15.552769 1647.6325 1663.5634
C5_01-007 1214.940 0.0 9.344536 5354.1800 5383.5693
C5_03-004 1311.600 0.5 10.027999 3791.8175 3802.0893
C6_03-005 731.660 0.0 77.867546 1869.4250 1949.1858
C6_02-007 444.990 0.0 13.289757 1956.7900 1970.4029

Summary

Parameter irinotecan, N = 171 SN-38, N = 171 SN-38G, N = 171
CMAX 481.291 ± 239.339 590.710 ± 312.784 614.598 ± 474.079
LAMZHL 11.430 ± 4.444 22.600 ± 26.625 24.029 ± 18.090
AUCLST 2,718.855 ± 1,805.316 1,027.618 ± 757.709 2,484.813 ± 1,754.701
AUCIFO 2,783.210 ± 1,815.559 1,069.939 ± 783.684 2,527.663 ± 1,748.679
1 Mean ± SD

Dose-normalized NCA results

After administration (time >= 0)

Irinotecan

Subject Dose CMAX_dn AUCLST_dn AUCIFO_dn
C1_01-001 8.4 8.405952 19.18905 23.63245
C2_03-001 17.6 4.167046 21.69261 22.55263
C3_02-002 30.9 7.423948 82.46116 91.01815
C4_03-002 49.6 5.492137 26.13816 27.28538
C4_02-003 50.4 14.320833 31.16290 31.85951
C4_01-002 46.5 10.565161 46.71763 47.58505
C4_01-003 47.7 5.697275 29.05110 29.65614
C4_01-004 47.4 14.029114 58.80628 59.54154
C5_02-004 50.3 9.135984 43.16168 44.52855
C5_03-003 49.9 11.013828 49.43753 50.72911
C5_01-006 68.0 7.145294 61.85103 62.74659
C5_02-005 65.2 10.213190 114.31196 115.43194
C5_02-006 77.1 8.684176 41.70700 42.49091
C5_01-007 60.4 10.969040 93.22413 94.20881
C5_03-004 57.7 7.570017 41.34957 42.43877
C6_03-005 83.6 5.941866 32.75206 33.51527
C6_02-007 74.5 12.884295 48.98866 49.89359

SN-38

Subject Dose CMAX_dn AUCLST_dn AUCIFO_dn
C1_01-001 8.4 17.202619 17.668274 18.722850
C2_03-001 17.6 5.470454 9.063068 9.292165
C3_02-002 30.9 4.032686 18.645388 19.236234
C4_03-002 49.6 6.510887 9.542994 13.202119
C4_02-003 50.4 11.492857 11.513443 11.797693
C4_01-002 46.5 16.078710 24.542527 24.829302
C4_01-003 47.7 11.038365 19.532076 19.944123
C4_01-004 47.4 23.368354 27.118776 27.758495
C5_02-004 50.3 10.487475 19.012276 20.963461
C5_03-003 49.9 14.481363 22.743687 22.966499
C5_01-006 68.0 10.038088 28.800184 29.537335
C5_02-005 65.2 13.956595 51.687807 54.129007
C5_02-006 77.1 11.198184 13.885798 14.233112
C5_01-007 60.4 13.578477 21.765190 22.119715
C5_03-004 57.7 6.879376 11.658796 11.951892
C6_03-005 83.6 5.016388 6.221531 6.311420
C6_02-007 74.5 14.095570 15.782013 16.292219

SN-38G

Subject Dose CMAX_dn AUCLST_dn AUCIFO_dn
C1_01-001 8.4 19.651429 75.85440 78.68067
C2_03-001 17.6 10.130682 36.90625 41.44500
C3_02-002 30.9 6.012298 31.17791 31.93802
C4_03-002 49.6 5.261089 25.89808 28.81528
C4_02-003 50.4 6.031944 20.34762 20.97971
C4_01-002 46.5 6.446452 27.95651 28.52437
C4_01-003 47.7 27.184486 81.73852 83.90191
C4_01-004 47.4 35.207595 83.42780 83.91660
C5_02-004 50.3 4.813718 29.45656 30.20634
C5_03-003 49.9 7.855711 31.06638 31.68262
C5_01-006 68.0 10.706765 86.61526 86.93866
C5_02-005 65.2 9.002147 76.48305 76.98288
C5_02-006 77.1 5.660700 21.37007 21.57670
C5_01-007 60.4 20.114901 88.64536 89.13194
C5_03-004 57.7 22.731369 65.71607 65.89410
C6_03-005 83.6 8.751914 22.36154 23.31562
C6_02-007 74.5 5.973020 26.26564 26.44836

Summary

Parameter irinotecan, N = 171 SN-38, N = 171 SN-38G, N = 171
Dose 52.071 ± 19.816 52.071 ± 19.816 52.071 ± 19.816
CMAX_dn 9.039 ± 3.009 11.466 ± 5.026 12.443 ± 9.094
AUCLST_dn 49.530 ± 26.084 19.364 ± 10.550 48.899 ± 27.334
AUCIFO_dn 51.124 ± 26.551 20.193 ± 10.847 50.022 ± 27.332
1 Mean ± SD

From the beginning of administration (time >= -2)

Irinotecan

Subject Dose CMAX_dn AUCLST_dn AUCIFO_dn
C1_01-001 8.4 8.405952 19.18905 23.63245
C2_03-001 17.6 4.167046 21.69261 22.55263
C3_02-002 30.9 7.423948 82.46116 91.01815
C4_03-002 49.6 5.492137 26.13816 27.28538
C4_02-003 50.4 14.320833 31.16290 31.85951
C4_01-002 46.5 10.565161 46.71763 47.58505
C4_01-003 47.7 5.697275 29.05110 29.65614
C4_01-004 47.4 14.029114 58.80628 59.54154
C5_02-004 50.3 9.135984 43.16168 44.52855
C5_03-003 49.9 11.013828 49.43753 50.72911
C5_01-006 68.0 7.145294 61.85103 62.74659
C5_02-005 65.2 10.213190 114.31196 115.43194
C5_02-006 77.1 8.684176 41.70700 42.49091
C5_01-007 60.4 10.969040 93.22413 94.20881
C5_03-004 57.7 7.570017 41.34957 42.43877
C6_03-005 83.6 5.941866 32.75206 33.51527
C6_02-007 74.5 12.884295 48.98866 49.89359

SN-38

Subject Dose CMAX_dn AUCLST_dn AUCIFO_dn
C1_01-001 8.4 17.202619 17.668274 18.722850
C2_03-001 17.6 5.470454 9.063068 9.292165
C3_02-002 30.9 4.032686 18.645388 19.236234
C4_03-002 49.6 6.510887 9.542994 13.202119
C4_02-003 50.4 11.492857 11.513443 11.797693
C4_01-002 46.5 16.078710 24.542527 24.829302
C4_01-003 47.7 11.038365 19.532076 19.944123
C4_01-004 47.4 23.368354 27.118776 27.758495
C5_02-004 50.3 10.487475 19.012276 20.963461
C5_03-003 49.9 14.481363 22.743687 22.966499
C5_01-006 68.0 10.038088 28.800184 29.537335
C5_02-005 65.2 13.956595 51.687807 54.129007
C5_02-006 77.1 11.198184 13.885798 14.233112
C5_01-007 60.4 13.578477 21.765190 22.119715
C5_03-004 57.7 6.879376 11.658796 11.951892
C6_03-005 83.6 5.016388 6.221531 6.311420
C6_02-007 74.5 14.095570 15.782013 16.292219

SN-38G

Subject Dose CMAX_dn AUCLST_dn AUCIFO_dn
C1_01-001 8.4 19.651429 75.85440 78.68067
C2_03-001 17.6 10.130682 36.90625 41.44500
C3_02-002 30.9 6.012298 31.17791 31.93802
C4_03-002 49.6 5.261089 25.89808 28.81528
C4_02-003 50.4 6.031944 20.34762 20.97971
C4_01-002 46.5 6.446452 27.95651 28.52437
C4_01-003 47.7 27.184486 81.73852 83.90191
C4_01-004 47.4 35.207595 83.42780 83.91660
C5_02-004 50.3 4.813718 29.45656 30.20634
C5_03-003 49.9 7.855711 31.06638 31.68262
C5_01-006 68.0 10.706765 86.61526 86.93866
C5_02-005 65.2 9.002147 76.48305 76.98288
C5_02-006 77.1 5.660700 21.37007 21.57670
C5_01-007 60.4 20.114901 88.64536 89.13194
C5_03-004 57.7 22.731369 65.71607 65.89410
C6_03-005 83.6 8.751914 22.36154 23.31562
C6_02-007 74.5 5.973020 26.26564 26.44836

Summary

Parameter irinotecan, N = 171 SN-38, N = 171 SN-38G, N = 171
Dose 52.071 ± 19.816 52.071 ± 19.816 52.071 ± 19.816
CMAX_dn 9.039 ± 3.009 11.466 ± 5.026 12.443 ± 9.094
AUCLST_dn 49.530 ± 26.084 19.364 ± 10.550 48.899 ± 27.334
AUCIFO_dn 51.124 ± 26.551 20.193 ± 10.847 50.022 ± 27.332
1 Mean ± SD

Simple covariate analysis using correlation & linear regression

Correlation plot

Linear regression (Univariate) result

Characteristic LAMZHL CMAX_dn AUCLST_dn
Beta 95% CI1 p-value Beta 95% CI1 p-value Beta 95% CI1 p-value
sex
남성 — — — — — —
여성 7.8 -13, 28 0.45 -6.8 -13, -0.17 0.045 -4.4 -33, 24 0.76
age 0.37 -0.38, 1.1 0.33 -0.03 -0.27, 0.21 0.79 0.40 -0.64, 1.4 0.44
WT 0.53 -1.9, 3.0 0.66 0.60 -0.19, 1.4 0.13 1.1 -2.3, 4.5 0.52
BSA -16 -202, 170 0.86 -53 -113, 6.5 0.079 -96 -354, 162 0.46
1 CI = Confidence Interval

Simple distribution for categorical variable (sex)

LAMZHL

CMAX_dn

AUCLST_dn